Legal Document View

Unlock Advanced Research with PRISMAI

Integrated with over 4 crore judgments and laws — designed for legal practitioners, researchers, students and institutions

- Know your Kanoon - Doc Gen Hub - Counter Argument - Case Predict AI - Talk with IK Doc - ...
Upgrade to Premium
[Cites 0, Cited by 0] [Entire Act]

Union of India - Section

Section 74 in The Drugs and Cosmetics Rules, 1945

74. [ Conditions of license in [Form 25 and Form 25-F] [Substituted by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).].

- A license in [Form 25 and Form 25-F] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] shall be subject to the conditions stated therein and to the following further conditions, namely:-
(a)the licensee shall provide and maintain staff, premises and the equipment as specified in rule 71;
(b)the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force, four months after publication in the Official Gazette;
(c)the licensee shall either in his own laboratory or in any other laboratory approved by the licensing authority [under Part XV(A) of these rules] [Inserted by G.S.R. 1172, dated 23.8.1977 (w.e.f. 10.9.1977).] test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of manufacture;
(d)the licensee shall keep records of the details of manufacture as per particulars given in Schedule U of each batch of the drugs manufactured by him and such records shall be retained for a period of five years;
(e)the licensee shall allow an [Inspector appointed under the Act] [Substituted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture and the means employed in standardizing and testing the drugs;
(f)the licensee shall allow an [Inspector appointed under the Act] [Substituted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules thereunder have been observed;
(g)the licensee shall, from time to time, report to the licensing authority any changes in the expert staff responsible for the manufacture or testing of the drugs and any material alterations in the premises or plant used for the purpose which have been made since the date of the last inspection made on behalf of the licensing authority;
(h)[ the licensee shall, on request, furnish to the licensing authority, the controlling authority or to such authorities as the licensing authority or the controlling authority may direct, from every batch or batches of drugs as the licensing authority or the controlling authority may from time to time specify, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of tests which have been applied;] [Substituted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
(i)if the licensing authority [or the controlling authority] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] so directs and if requested by the licensee who had also furnished prima facie reasons for such directions, the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under clause (h) until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the licensing authority [or the controlling authority] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).];
(j)the licensee shall on being informed by the licensing authority [or the controlling authority] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] that any part of any batch of the drug has been found by the licensing authority [or the controlling authority] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch;
(k)the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed;]
(l)[ the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
(m)[ the licensee, who has been granted a license in Form 25-F, shall- [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
(i)forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to the manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months;
(ii)maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later:-
A. Account of the drugs specified in Schedule X used for the manufacture :-
1. Date of issue.
2. Name of the drug.
3. Opening balance of stock on the production day.
4. Quantity received, if any, and source from where received.
5. Quantity used in manufacture
6. Balance quantity on hand at the end of the production day.
7. Signature of the person in charge
B. Account of production:-
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Quantity of raw material used in manufacture.
5. Anticipated yield.
6. Actual yield.
7. Wastage.
8. Quantity of the manufactured goods transferred.
C. Accounts of the manufactured drugs:-
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Opening Balance.
5. Quantity manufactured.
6. Quantity sold.
7. Name of the purchaser and his address.
8. Balance quantity at the end of the day.
9. Signature of the person in charge.
(n)The licensee shall store drugs specified in Schedule X in bulk form and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person.]
(o)[ The licensee shall comply with the requirements of [Good Laboratory Practices as laid down in Schedule L-I and ] [Inserted by G.S.R. 735, dated 24.6.1988 (w.e.f. 24.6.1988).]["Good Manufacturing Practices" as laid down in Schedule M.] [Inserted by G.S.R. 735, dated 24.6.1988 (w.e.f. 24.6.1988).]
(p)[ No advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with the previous sanction of the Central Government.] [Inserted by Notification No. G.S.R. 289(E), dated 15.4.2015 (w.e.f. 21.12.1945)]
(q)[ the applicant shall submit the result of bio-equivalence study referred to in Schedule Y, along with the application for grant of a licence of oral dosage form of drugs specified under category II and category IV of the bio-pharmaceutical classification system.] [Inserted by Notification No. G.S.R. 327(E), dated 3.4.2017 (w.e.f. 21.12.1945).]